BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCEPTRE/ECAT EMERGE

    MDR report key: 676811 · Received February 13, 2006

    Report

    Report Number
    1034973-2006-00001
    Event Type
    Malfunction
    Date Received
    February 13, 2006
    Date of Event
    March 1, 2005
    Report Date
    June 2, 2005
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    KPS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN INCREASE IN THE STANDARD UPDATE VALUE (SUV) WAS REPORTED AFTER THE CUSTOMER UPGRADED FROM PETSYNGO 7.2.2 RELEASE 1 TO 7.2.2 RELEASE 4A SOFTWARE. THE INCREASE WAS MORE EVIDENT IN HEAVIER PATIENTS. THERE IS THE POTENTIAL THAT A HIGH SUV (UPON A FOLLOW-UP SCAN) COULD BE MISINTERPRETED AND IMPACT A PATIENT'S TREATMENT PLAN. HOWEVER, SIEMENS MEDICAL SOLUTIONS USA, INC. HAS NOT RECEIVED ANY REPORTS WHICH INDICATE THIS HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCEPTRE/ECAT EMERGE PET SCANNER KPS SIEMENS MEDICAL SOLUTIONS USA, INC. 3600099-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other